A Phase 1 interventional study of PLT012 in Advanced Malignant Solid Tumor and Solid Tumor Cancer, sponsored by Pilatus Biosciences Inc. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Pilatus Biosciences Inc · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to learn about what doses of PLT012 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of PLT012 are in treating cancer. The main questions it aims to answer are:
What adverse events and toxicities (harmful side effects) are associated with different doses of PLT012? What are the blood levels of PLT012 in your body at different timepoints? What effect does PLT012 have on reducing tumor size and/or preventing the worsening of cancer? All participants will receive PLT012 and none will receive placebo (a look-alike substance that contains no drug).
Participants will receive PLT012 by intravenous infusion once every 3 weeks. Treatment with PLT012 can continue until the participant's disease worsens or they cannot tolerate treatment.
For the first 12 weeks, visits to the clinic will be more frequent (from 1 to 5 times over a 3-week period). After the first 12 weeks, visits will be reduced to once every 3 weeks.
This study is a phase 1, open label, dose escalation and dose expansion study using an initial single participant cohort followed by a BOIN design to evaluate multiple ascending doses of PLT012.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →This is the only study on the registry with Pilatus Biosciences Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PLT012 administered via intravenous infusion once every 3 weeks
Drug: PLT012
PLT012 (anti-CD36 monoclonal antibody)
Frequency, type and severity of dose limiting toxicities and adverse events
Frequency, type and severity of dose limiting toxicities and adverse events according to NCI CTCAE v5.0
Time frame: 18 months
Pharmacokinetic Properties of PLT012
Plasma concentration of PLT012 at each timepoint at different dose levels
Time frame: 18 months
Immunogenicity of PLT012
Percentage and titer of the anti-drug antibody (ADA) at different dose levels of PLT012
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by Overall Response Rate (ORR)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by disease control rate (DCR)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by time to response (TTR)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by duration of response (DOR)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by progression-free survival (PFS)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by overall survival (OS)
Time frame: 18 months
Plan to share: Undecided — Pilatus will likely provide this data, but need to formalize the plan first.
No publications or documents are linked to this record.
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